drugset / Trial / NCT00171301

Extension Study of the Efficacy and Safety of Deferasirox Treatment in Beta-thalassemia Patients With Transfusional Hemosiderosis (Study Amended to 2-year Duration)

NCT00171301

Phase 4 Completed 233 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

To allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available. To evaluate the long-term safety and efficacy of deferasirox by measuring treatment success, change in liver iron content (LIC) and change in serum ferritin levels. Safety was mainly assessed by incidence of adverse events (AEs)and clinically significant lab parameters.

Timeline

Start
2005-06
Primary completion
2008-05
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferasirox Unknown 10 mg/kg Oral
Subject Deferasirox Unknown 20 mg/kg Oral